PATIENT INFORMATION LEAFLET: INFORMATION FOR THE PATIENT
Pizotifen 0.5mg and 1.5mg Film-Coated Tablets
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. • Keep this leaflet. You may need to read it again. • If you have any further question, ask your doctor or pharmacist. • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See Section 4.
What is in this leaflet: 1. What Pizotifen is and what it is used for 2. What you need to know before you take Pizotifen 3. How to take Pizotifen 4. Possible side effects 5. How to store Pizotifen 6. Contents of the pack and other information
1. What Pizotifen is and what it is used for Pizotifen is an anti−migraine medicine.
Pizotifen tablets are used to help prevent or reduce the pain of headaches, cluster headaches and migraines.
Pizotifen will not relieve a migraine once it has started.
2 What you need to know before you take Pizotifen Do not take Pizotifen if: • you are allergic to pizotifen or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions Talk to your doctor before taking Pizotifen if: • you suffer from liver or kidney problems (your dose may need to be adjusted) • you have difficulty passing urine (e.g. an enlarged prostate gland) • you suffer from closed angle glaucoma (increased pressure in the eye) • you have a history of epilepsy
Other medicines and Pizotifen Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those obtained without a prescription. This includes herbal medicines.
Medicines which may interact with or be affected by Pizotifen: • Medicines to help you sleep (hypnotics), such as nitrazepam • Medicines which help to relieve anxiety (sedatives), such as diazepam • Medicines used to relieve allergies (antihistamines), including some common cold medicines • Medicines used to lower blood pressure (adrenergic neurone blockers), such as guanethidine
Taking Pizotifen with alcohol You should not drink alcohol whilst taking Pizotifen.
Pregnancy and breast−feeding If you are pregnant or breast−feeding, think you might be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Pregnancy You should not take Pizotifen unless the expected benefits outweigh the potential risks. Breast-feeding The use of pizotifen is not recommended whilst breast-feeding.
Driving and using machines Pizotifen may cause drowsiness, tiredness or dizziness. If this occurs, you should not drive or operate machinery.
Pizotifen contains lactose If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicine.
3 How to take Pizotifen Always take Pizotifen exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
• These tablets are to be taken orally.
Adults (including the elderly) • The usual dose is 1.5mg daily. • This may be taken as a single dose at night or in three divided doses. • 3mg is the maximum that may be given as a single daily dose. • The maximum dose is 4.5mg daily.
Use in children (aged 2 years and over) • Up to 1.5mg daily, usually taken as a divided dose. • Up to 1mg has been given as a single dose at night.
Patients with kidney or liver problems Dosage adjustment may be necessary.
If you take more Pizotifen than you should If you accidentally take too many tablets, contact your doctor or nearest hospital emergency department immediately for advice. Remember to take this leaflet or any remaining tablets with you. Symptoms of an overdose include: drowsiness, dizziness, fever, confusion, fits (convulsions) or excitement (particularly in children), difficulty in breathing (dyspnoea, respiratory paralysis), fast heartbeat (tachycardia), low blood pressure (hypotension), dry mouth, lack of voluntary co-ordination of muscle movements (unsteadiness or clumsiness) (ataxia), feeling sick (nausea) or being sick (vomiting), abnormal blueness of the skin (cyanosis), coma.
If you forget to take Pizotifen Take it as soon as you remember, unless it is time for your next dose. If you miss a dose, do not take a double dose to make up for a forgotten dose.
If you stop taking Pizotifen It is important that you keep taking Pizotifen for as long as your doctor has told you to.
Pizotifen should be reduced gradually. If you suddenly stop your treatment with Pizotifen, the following withdrawal symptoms may occur: depression, shaking (tremor), feeling sick (nausea), anxiety, generally feeling unwell (malaise), dizziness, sleep disorders, weight loss.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4 Possible side effects Like all medicines, Pizotifen can cause side effects, although not everybody gets them.
Seek medical advice immediately if you develop the following symptoms: • Allergic reactions: swelling of the face, throat or tongue, difficulty in breathing, dizziness
Very common side effects (may affect more than 1 in 10 people) • Increase in appetite, which may lead to weight gain
Common side effects (may affect up to 1 in 10 people) • Drowsiness or sleepiness (somnolence) • Dizziness • Dry mouth • Feeling sick (nausea) • Feeling tired (fatigue)
Uncommon side effects (may affect up to 1 in 100 people) • Constipation
Rare side effects (may affect up to 1 in 1,000 people) • Tingling or numbness in the hands or feet (paraesthesia) • Skin rashes, including with the formation of wheals (urticaria) • Muscle pain (myalgia) • Pain or swelling in the joints (arthralgia) • Depression • Aggression or agitation • Anxiety • Seeing or hearing things that are not real (hallucinations) • Difficulty in sleeping (insomnia) and sleep disorders
Very rare side effects (may affect up to 1 in 10,000 people) • Fits (seizures)
Other side effects (frequency unknown) • Increase in liver enzyme (detected in blood tests) • Yellowing of the skin or whites of the eyes (jaundice) • Inflammation of the liver (hepatitis) • Muscle cramps
Withdrawal symptoms If you suddenly stop taking Pizotifen you may experience withdrawal symptoms (see ‘If you stop taking Pizotifen’, section 3)
Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
5 How to store Pizotifen • Keep this medicine out of the sight and reach of children. • Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month. • Store below 25ºC. Store in the original package. • Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
6. Contents of the pack and other information
What Pizotifen tablets contain: • Each 0.5mg tablet contains Pizotifen malate equivalent to Pizotifen 0.5mg • Each 1.5mg tablet contains Pizotifen malate equivalent to Pizotifen 1.5mg
The other ingredients are: lactose monohydrate, microcrystalline cellulose, magnesium stearate, purified water, hypromellose (E464), titanium dioxide (E171), macrogol, iron oxides (yellow and black) (E172), and quinoline yellow aluminium lake (E104)
What Pizotifen tablets look like and the contents of the pack: • Pizotifen 0.5mg are pale cream to yellow, circular, biconvex, film-coated tablets, with an approximate diameter of 6mm, marked ‘PZT 0.5’ on one face • Pizotifen 1.5mg are pale cream to yellow, circular, biconvex, film-coated tablets, with an approximate diameter of 9.1mm, marked ‘PZT 1.5’ on one face
Pizotifen is available in: • Pizotifen 0.5mg tablets are available in blister packs or containers of 28 and 84 tablets. • Pizotifen 1.5mg tablets are available in blister packs or containers of 28 tablets.
Not all pack sizes or types may be marketed.
Marketing Authorisation Holder and Manufacturer: Tillomed Laboratories Ltd 220 Butterfield Great Marlings Luton LU2 8DL United Kingdom
Product Licence Numbers: • Pizotifen 0.5mg Tablets - PL 11311/0379 • Pizotifen 1.5mg Tablets - PL 11311/0380
This leaflet was last revised in June 2021
Till− Ver.8